Clinical Auditor III – GCP

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee intricate internal and external audits to guarantee adherence to quality assurance processes, standards, global regulatory requirements, and client contractual obligations.

• Detect quality and regulatory compliance challenges, evaluate root causes of non-conformance, and formulate risk-mitigation approaches.

• Perform technical document assessments and engage in Good Clinical Practice activities that support clinical projects and company operations.

• Conduct and/or direct audits for clients, internal teams, Good Clinical Practice, clinical sites, facilities, processes, databases, clinical study reports, and vendors.

• Assist during regulatory inspections and act as a co-auditor on intricate system audits.

• Offer Good Clinical Practice consultation and quality support to project teams and external clients.

• Execute sample results table evaluations and initiatives for process improvement.

• Act as a subject matter expert for operational teams regarding audit and quality assurance matters.

• Prepare, communicate, and present audit outcomes and quality-related information in departmental meetings, internal operations, and client gatherings.

• Mentor, guide, and provide subject matter expertise to junior auditors.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic or vocational qualification.

• Over 5 years of prior experience in Quality Assurance.

• Audit experience in a regulated industry; experience in clinical research or pharmaceuticals is highly preferred.

• Comprehensive knowledge of Good Clinical Practice (GCP) and relevant regional clinical research regulations and guidelines.

• Experience in leading project-based and/or internal GCP audits and vendor audits.

• Exceptional written and verbal communication abilities.

• Strong capabilities in problem-solving, risk assessment, and impact analysis.

• Experience in conducting root cause analyses.

• Proficient negotiation and conflict management skills.

• Ability to thrive in a dynamic environment, manage multiple priorities, and balance conflicting demands and workloads.

• Willingness to travel as needed, up to 50% within the US and potentially internationally.

• Valid driver's license and the ability to meet company travel requirements.

• Capacity to communicate, receive, and understand information and ideas among diverse groups of individuals.

• Capability to maintain an upright and stationary position for standard working hours.

• Proficiency in using and learning standard office equipment and technology.

• Ability to perform effectively under pressure while prioritizing and managing multiple projects or activities.

• Must possess legal authorization to work in the United States without sponsorship.

• Must successfully pass a thorough background check, including drug screening.

🏝️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results in line with company policy.

• Reasonable accommodations for individuals with disabilities.

• Opportunities for experience and professional growth.

• Relocation assistance is NOT provided.